Quality Assurance Specialist I- CAPA

Bausch + Lomb (NYSE/TSX: BLCO) is a leading global eye health company dedicated to protecting and enhancing the gift of sight for millions of people around the world—from the moment of birth through every phase of life. Our mission is simple, yet powerful: helping you see better, to live better.

Our comprehensive portfolio of over 400 products is fully integrated and built to serve our customers across the full spectrum of their eye health needs throughout their lives. Our iconic brand is built on the deep trust and loyalty of our customers established over our 170-year history. We have a significant global research, development, manufacturing and commercial footprint of approximately 13,000 employees and a presence in approximately 100 countries, extending our reach to billions of potential customers across the globe. We have long been associated with many of the most significant advances in eye health, and we believe we are well positioned to continue leading the advancement of eye health in the future.

Objectives/Purpose of Job:

Reporting directly to the Manager, Quality Systems & Compliance (QSC), this role is the CAPA coordinator for the site. This role is also responsible for performing routine Quality System tasks as assigned and lead/execute various Quality System improvement projects.

Key Activities/Responsibilities:

Safety: Demonstrate safety performance behaviors and engage actively to promote.

Compliance: Coordinates CAPA related activities to ensure timely closure and effective plans. Conducts internal audits as needed. Supports regulatory and third-party inspections for the site. Interfaces with outside regulatory and legal authorities as appropriate. Write, review, revise and approve procedures and specifications, as needed.

Provide oversight for various quality system elements and tools. Works with quality, operations, distribution to ensure sound and timely decisions/investigations are made/written regarding nonconformance and root cause, CAPA analysis. Acts as a liaison between retail customers and operations / quality.

Managing, Planning and Directing: Manage the CAPA system and associated CAPA board. Promote open communications within the site and with external contacts. Lead and execute various projects to enhance the site’s quality systems. Provide quality systems assistance for site functions. Review/approve investigation reports.

Continuous Improvement: Maintain and continually improve quality documentation and investigations. Write and review SOPs with a focus on improved content. Contribute to QPI improvement activities.

Additional activities to support Quality System Compliance Department as needed.

Qualifications:

Education

• Bachelor's degree in a scientific, engineering, or other technical discipline required.
• Specialized training in 21 CFR Part 211, 21 CFR Part 820, ISO 9001:2000, and ISO 13485 preferred.
• Proficiency with database applications, including Microsoft Excel and Microsoft Access.
• Experience with quality management systems/databases such as D2 and CQMS preferred.

Experience

• 3+ years of Quality Assurance experience in an FDA-regulated manufacturing or distribution environment required.
• Experience in pharmaceutical (drug) or medical device manufacturing preferred.
• Strong understanding of CAPA processes and quality system requirements, with the ability to identify root causes, evaluate corrective actions, and drive timely closure of CAPA records highly preferred.

Knowledge, Skills & Abilities

• Demonstrated technical writing and documentation skills.
• Strong analytical and critical thinking abilities.
• Ability to effectively communicate and build relationships with employees at all levels of the organization.
• Strong organizational skills with the ability to manage multiple priorities and work independently with minimal supervision.
• Excellent verbal and written communication skills, including the ability to effectively interact with cross-functional teams and customers.
• Excellent time management and project prioritization skills.
• Experience conducting internal or external quality audits preferred.
• Experience leading or participating in quality investigations and root cause analysis preferred.

This position may be available in the following location(s): US - Greenville, SC (Plant)

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

U.S. based employees may be eligible for short-term and/or long-term incentives. They may also be eligible to participate in medical, dental, vision insurance, disability and life insurance, a 401(k) plan and company match, a tuition reimbursement program (select degrees), company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive sick time, floating holidays and paid vacation.   

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To learn more please read Bausch + Lomb's Job Offer Fraud Statement.

Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.